Seasonal Allergic RhinoconjunctivitisPhase 1/2NCT00833066
Safety Study of Grass Pollen-derived Peptides to Treat Seasonal Allergic Rhinoconjunctivitis
A Phase 1/2 study testing gpASIT+TM in people with Seasonal Allergic Rhinoconjunctivitis, run by BioTech Tools S.A. at 4 sites in Belgium.
Trial summary
The purpose of this study is to determine whether the oral administration of grass pollen peptides is safe and effective in the treatment of allergic rhinitis. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Seasonal Allergic Rhinoconjunctivitis
- What is being tested?
- gpASIT+TM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 4 sitesBelgium
- Study dates
- Feb 2009to Nov 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject has given written informed consent
- Age between 18 and 50 years
- The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
- Male or non pregnant, non-lactating female
- Female unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period))
- Allergy:
- A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the two previous years A positive skin prick test (wheal diameter >= 3 mm) to grass-pollen mixture Specific IgE against grass pollen (RAST class 2 or IgE > 0.7 kU/l) Asymptomatic to perennial inhalant allergens.
Who cannot join
- Subjects with current or past immunotherapy (any time in the past)
- Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
- Documented evidence of acute or significant chronic sinusitis (as determined by individual investigator)
- Subjects with a history of hepatic or renal disease
- Subjects symptomatic to perennial inhalant allergens
- Subject with malignant disease, autoimmune disease
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- Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD)
- Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric or duodenal ulcer, uncontrolled diabetes mellitus, etc…)
- Subjects requiring beta-blockers medication
- Chronic use of concomitant medications that would affect assessment of the effectiveness of the trial medication (e.g. tricyclic antidepressants)
- Subject with febrile illness (> 37.5°C, oral)
- A known positive serology for HIV-1/2, HBs antigen or anti-HCV antibodies
- The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before trial entry
- Receipt of blood or a blood derivative in the past 6 months preceding trial entry
- Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the trial
- Any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the trial
- Use of long-acting antihistamines
- Any condition which could be incompatible with protocol understanding and compliance
- Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship
- Unreliable subjects including non-compliant subjects, subjects with known alcoholism or drug abuse or with a history of a serious psychiatric disorder as well as subjects unwilling to give informed consent or to abide by the requirements of the protocol
- Participation in another clinical trial and/or treatment with an experimental drug within 1 month of trial start
- A history of hypersensitivity to the excipients
- Rhinitis medicamentosa, non-specific rhinitis (to food dye, preservative agent…)
- Subjects without means of contacting the investigator rapidly in case of emergency, or not able to be contacted rapidly by the investigator
- Subjects who participated to trial BTT-gpASIT002
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
University Hospital Brugmann
Brussels, 1020
University Hospital Ghent
Ghent, 9000
University Hospital Gasthuisberg
Leuven, 3000
University Hospital Sart Tilman
Liège, 4000
About this study
Official title: Preliminary Assessment of the Clinical Tolerability, Safety and Immunogenicity of Three Different Doses of Grass Pollen-derived Peptides for Oral Use in Antigen-specific Immunotherapy of Seasonal Allergic Rhinoconjunctivitis
The purpose of this study is to determine whether the oral administration of grass pollen peptides is safe and effective in the treatment of allergic rhinitis.
- Conditions
- Seasonal Allergic Rhinoconjunctivitis
- Being tested
- gpASIT+TM, Placebo
- Keywords
- hay fever, grass pollen allergy
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gpASIT+TMBiological
entero-coated capsules containing 25µg of gpASIT+TM
PlaceboBiological
placebo entero-coated capsules
gpASIT+TMBiological
entero-coated capsules containing 100µg of gpASIT+TM
gpASIT+TMBiological
entero-coated capsules containing 400µg of gpASIT+TM
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
| gpASIT 25 | Experimental | Not described Receives: Biological: gpASIT+TM |
| gpASIT 100 | Experimental | Not described Receives: Biological: gpASIT+TM |
| gpASIT 400 | Experimental | Not described Receives: Biological: gpASIT+TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of allergic reaction
Measured: within the first 14 days (plus or minus 1 day)
Secondary outcomes (2)
Immunological assessment
Measured: 9 months
Allergy symptom and medication scores
Measured: grass pollen season 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinoconjunctivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioTech Tools S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833066
- Sponsor's protocol ID
- BTT-gpASIT003
- Other IDs
- EudraCT 2008-006369-10
- Status last verified
- Nov 2011
- First submitted
- 29 Jan 2009
- Last updated
- 17 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Assessment of the Clinical Tolerability, Safety and Immunogenicity of Three Different Doses of Grass Pollen-derived Peptides for Oral Use in Antigen-specific Immunotherapy of Seasonal Allergic Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT00833066
- Acronym / sponsor ID
- BTT-gpASIT003
- Conditions
- Seasonal Allergic Rhinoconjunctivitis
- Keywords
- hay fever, grass pollen allergy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- BioTech Tools S.A.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 30 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the oral administration of grass pollen peptides is safe and effective in the treatment of allergic rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Placebo |
| gpASIT 25 | Experimental | Biological: gpASIT+TM |
| gpASIT 100 | Experimental | Biological: gpASIT+TM |
| gpASIT 400 | Experimental | Biological: gpASIT+TM |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject has given written informed consent
- Age between 18 and 50 years
- The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status
- Male or non pregnant, non-lactating female
- Female unable to bear children must have documentation of such in the CRF (i.e. tubule ligation, hysterectomy, or post menopausal (defined as a minimum of one year since the last menstrual period))
Key exclusion criteria (25 listed)
- Subjects with current or past immunotherapy (any time in the past)
- Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids)
- Documented evidence of acute or significant chronic sinusitis (as determined by individual investigator)
- Subjects with a history of hepatic or renal disease
- Subjects symptomatic to perennial inhalant allergens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gpASIT+TMentero-coated capsules containing 25µg of gpASIT+TM | Biological | gpASIT 25 |
| Placeboplacebo entero-coated capsules | Biological | Placebo |
| gpASIT+TMentero-coated capsules containing 100µg of gpASIT+TM | Biological | gpASIT 100 |
| gpASIT+TMentero-coated capsules containing 400µg of gpASIT+TM | Biological | gpASIT 400 |
Primary outcome
Evidence of allergic reaction
Time frame: within the first 14 days (plus or minus 1 day)
2 secondary outcomes
Immunological assessment
Time frame: 9 months
Allergy symptom and medication scores
Time frame: grass pollen season 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing gpASIT+TM in people with Seasonal Allergic Rhinoconjunctivitis, run by BioTech Tools S.A. at 4 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of allergic reaction (time frame: within the first 14 days (plus or minus 1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2011.